Pain management after ambulatory surgery: a prospective, multicenter, randomized, double-blinded parallel controlled trial comparing nalbuphine and tramadol

Abstract

Background: Postoperative pain in ambulatory surgery is a multifactorial issue affecting patient satisfaction, time of discharge, and rehospitalization. This study evaluated the efficacy and safety of nalbuphine for the treatment of postoperative pain after ambulatory surgery, relative to tramadol. Methods: This multi-center, randomized, double blind, and controlled study was conducted at 10 centers. In accordance with the inclusion criteria, 492 ambulatory surgery patients were recruited. These patients had moderate to severe pain after ambulatory surgery, with a visual analogue scale (VAS) score > 3 cm. They were randomly divided into an experimental (n = 248) or control (n = 244) group and treated for analgesia with 0.2 mg/ kg of nalbuphine or 2 mg/kg of tramadol, respectively. VAS scores, adverse events, and vital signs of the patients were recorded before administration (baseline; T 1); and 30 min (T 2), 2 h (T 3), 4 h (T 4), and 6 h (T 5) after administration of analgesia. A decrease in pain intensity of more than 25% compared with the baseline was used as an indicator of analgesic efficacy. The experimental and control groups were compared with regard to this indicator of efficacy at each timepoint. Results: The VAS scores of the experimental and control groups were statistically comparable at timepoints T 1-T 4. At T 5 , the VAS scores of the experimental group were significantly lower than that of the control. The pain intensity was significantly higher in the experimental group compared with the control at T 2 and T 3. Adverse events and vital signs were similar for the two groups at each timepoint. Conclusions: Nalbuphine can provide effective and safe pain relief in patients after ambulatory surgery. Trial registration: The registration number is ChiCTR-IOR-16010032, the date of registration was 2016-11-28.

Pharmacokinetic comparison of nalbuphine with single injection and patient‐controlled analgesia mimic method in healthy Chinese volunteers

“…Moreover, because nalbuphine has very weak reactivity with delta (δ) receptors, this drug is expected to cause reduced irritability or anxiety 5,6 . In the clinical setting, pretreatment with nalbuphine can effectively reduce propofol‐induced injection pain and propofol consumption as well as ameliorate postoperative hyperalgesia induced by high‐dose remifentanil or sufentanil 7–9 . Nalbuphine exhibits a higher therapeutic index owing to its reduced incidence of adverse events (AEs), but has analgesic effects similar to those of morphine 10 .…”

Application of postoperative analgesia with different doses of nalbuphine in children with cleft palate

“…In recent years, efforts have been made to improve the pain management of children during perioperative period [13]. Unfortunately, the number of analgesic agents available for postoperative use in pediatric populations is very limited, particularly when a patient has "nothing per oral" status [14]. In China, the operation of cleft palate repair starts around 8 months, which is earlier than the time recommended by the American Craniofacial Federation for cleft palate, Therefore, we face more di culties and challenges in postoperative analgesia [3].…”

Effect of nalbuphine on rocuronium injection pain

“…It also works quickly and lasts long and therefore can be used for pediatric postoperative analgesia. 19 According to the Chinese Society of Anesthesiology, in principle, systemic opioids should be less used for patients who need surgery 20 because they often cause excessive sedation and respiratory inhibition, even nausea, vomiting, pruritus, and urinary retention. 21 A meta-analysis of randomized controlled trials showed that compared with morphine, nalbuphine had similar analgesic effects 22 but lack opioid-related adverse effects, such as itching.…”